Work

Quantitative OCT-Raman spectral imaging for intra-operative detection of positive margins in breast conserving surgery: a diagnostic accuracy study protocol

Year: 2026

Type: article

Abstract: Background Breast conserving surgery is the standard treatment for early-stage breast cancer; however, incomplete tumour excision remains a significant clinical challenge. Histopathological assessment identifies positive or close surgical margins in approximately 20% of patients, often necessitating additional surgery. Existing intra-operative margin assessment techniques are limited by their diagnostic performance, workflow requirements, or resource demands. Optical Coherence Tomography (OCT) and Raman spectroscopy are complementary optical imaging technologies that provide structural and biochemical tissue information and may enable rapid assessment of surgical margins during surgery. Methods This single-centre cross-sectional diagnostic accuracy study will evaluate an integrated OCT-Raman imaging platform for intra-operative margin assessment following breast conserving surgery. The study will be conducted at the University of Nottingham and Nottingham University Hospitals NHS Trust. Freshly excised surgical specimens will undergo OCT-Raman imaging immediately after resection, with histopathological assessment serving as the reference standard. The platform combines OCT imaging, Raman spectroscopy, automated machine learning algorithms, and real-time tissue classification software. A total of 272 specimens will contribute to algorithm development, optimisation, and independent validation. The primary outcome is diagnostic accuracy for detecting positive surgical margins. Secondary outcomes include workflow feasibility, inter-observer agreement, and assessment of tissue quality following imaging. Diagnostic performance will be evaluated using sensitivity, specificity, predictive values, and likelihood ratios. Results Algorithm training will be completed using annotated datasets derived from breast surgical specimens. The study will then undergo cross-validation and fine-tuning using data from 32 patients before independent validation in 120 patients. Conclusions This study will assess the diagnostic accuracy and clinical feasibility of an integrated OCT-Raman imaging platform for intra-operative margin assessment during breast conserving surgery. If validated, this approach could support intra-operative decision-making and help reduce the need for repeat surgical procedures.

Source: F1000Research

DOI: 10.12688/f1000research.187397.1